DepressionNCT01899534
Mental Health E-screening in Pregnant and Postpartum Women
A study testing E-screening in people with Depression and Anxiety, run by University of Calgary at 3 sites in Canada.
Trial summary
To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- E-screening
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 3 sitesCanada
- Study dates
- Jul 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and postpartum women will be eligible for this study if they:
- receive care at the recruitment sites ;
- can read/write English; and
- are willing to complete e-screening
Who cannot join
- do not receive care at the recruitment site;
- cannot read/write English;
- are not willing to complete e-screening
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Dickensfield Primary Care Maternity Clinic
Edmonton, Alberta, T5E 6A3
Royal Alexandra Hospital: Lois Hole Hospital for Women
Edmonton, Alberta, T5H 3V9
Sturgeon Primary Care Maternity Clinic
St. Albert, Alberta, T8N 6C4
About this study
To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. We also aim to identify factors associated with feasibility of e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.
Read the detailed description
Given that it is critical to conduct screening within a system that links referral and treatment, our IMPACT pilot trial is evaluating integrated screening and care (see Summary of Progress) versus usual prenatal care. The proposed trial engages 2 unique clinics with experienced staff who conduct routine screening (with referrals and treatment in place) to evaluate different modalities of screening. Since widespread screening is unlikely to be successfully implemented if it entails additional human resources, this trial assesses the potential for a sustainable, e-health alternative.
- Conditions
- Depression, Anxiety
- Being tested
- E-screening
- Keywords
- Pregnancy, Mental Health, Screening, Computer, Feasibility
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-screeningOther
E-screening will be conducted on a computer tablet with wireless access. The tablet will be configured with the screening tool currently used in each clinic. The content and order of individual questions will be identical to the paper-pen version. Response options will be listed in full view under each question. Women select responses by touching the screen.
| Study group | Role | What they receive |
|---|---|---|
| Paper-based screening | No intervention | Paper-based screening. Women will complete a mental health screening tool on paper (usual care). |
| E-screening | Experimental | Women will complete mental health screening on a tablet Receives: Other: E-screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).
All women will complete: 1) the Computer Violence Assessment Evaluation (CVAE) 38 (originally designed The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).to evaluate the feasibility/acceptability aspects of e- screening of domestic violence -Appendix C); and 2) open-ended investigator-developed questions on e-screening feasibility currently being pre-tested in another study (Appendix D).
Measured: 10 months
Secondary outcomes (3)
Proportion of pregnant and postpartum women with clinical depression and anxiety.
Measured in in pregnant women using the Antenatal Psychosocial Health Assessment (ALPHA)and the Edinburgh Postnatal Depression Scale. Measured in pregnant women using the Edinburgh Postnatal Depression Scale.
self-reported
Measured: on recruitment
Depression and anxiety
Mini Diagnostic Interview
-will be conducted either by telephone or in-person by a member of the research team who is a mental health expert
Measured: Within one week of recruitment
Cost-effectiveness of e-screening
We will observe the clinic process for a morning to determine the length of time it takes staff to conduct the both the usual screening process as well as the e-screening process (e.g., distribute tablets, follow-up with women). We will also interview the clinic manager to determine the costs of current screening process (e.g., time to screen, physical resources).
Measured: during recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dawn Kingston, University of Alberta
- Investigators
- Dawn A Kingston, Ph.D, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899534
- Sponsor's protocol ID
- 00039130
- Status last verified
- Oct 2016
- First submitted
- 10 Jul 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kingston D, Biringer A, Veldhuyzen van Zanten S, Giallo R, McDonald S, MacQueen G, Vermeyden L, Austin MP. Pregnant Women's Perceptions of the Risks and Benefits of Disclosure During Web-Based Mental Health E-Screening Versus Paper-Based Screening: Randomized Controlled Trial. JMIR Ment Health. 2017 Oct 20;4(4):e42. doi: 10.2196/mental.6888.
PubMed 29054833Kingston D, Austin MP, Veldhuyzen van Zanten S, Harvalik P, Giallo R, McDonald SD, MacQueen G, Vermeyden L, Lasiuk G, Sword W, Biringer A. Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 7;19(4):e88. doi: 10.2196/jmir.6866.
PubMed 28389421Kingston D, McDonald S, Biringer A, Austin MP, Hegadoren K, McDonald S, Giallo R, Ohinmaa A, Lasiuk G, MacQueen G, Sword W, Lane-Smith M, van Zanten SV. Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. Trials. 2014 Jan 2;15:3. doi: 10.1186/1745-6215-15-3.
PubMed 24383441
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health E-screening in Pregnant and Postpartum Women
- ClinicalTrials.gov ID
- NCT01899534
- Acronym / sponsor ID
- 00039130
- Conditions
- Depression, Anxiety
- Keywords
- Pregnancy, Mental Health, Screening, Computer, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. We also aim to identify factors associated with feasibility of e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.
Detailed description
Given that it is critical to conduct screening within a system that links referral and treatment, our IMPACT pilot trial is evaluating integrated screening and care (see Summary of Progress) versus usual prenatal care. The proposed trial engages 2 unique clinics with experienced staff who conduct routine screening (with referrals and treatment in place) to evaluate different modalities of screening. Since widespread screening is unlikely to be successfully implemented if it entails additional human resources, this trial assesses the potential for a sustainable, e-health alternative.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paper-based screening | No intervention | –Paper-based screening. Women will complete a mental health screening tool on paper (usual care). |
| E-screening | Experimental | Other: E-screeningWomen will complete mental health screening on a tablet |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant and postpartum women will be eligible for this study if they:
Key exclusion criteria (3 listed)
- do not receive care at the recruitment site;
- cannot read/write English;
- are not willing to complete e-screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-screeningE-screening will be conducted on a computer tablet with wireless access. The tablet will be configured with the screening tool currently used in each clinic. The content and order of individual questions will be identical to the paper-pen version. Response options will be listed in full view under each question. Women select responses by touching the screen. | Other | E-screening |
Primary outcome
The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).
Time frame: 10 months
All women will complete: 1) the Computer Violence Assessment Evaluation (CVAE) 38 (originally designed The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening).to evaluate the feasibility/acceptability aspects of e- screening of domestic violence -Appendix C); and 2) open-ended investigator-developed questions on e-screening feasibility currently being pre-tested in another study (Appendix D).
3 secondary outcomes
Proportion of pregnant and postpartum women with clinical depression and anxiety.
Time frame: on recruitment
Depression and anxiety
Time frame: Within one week of recruitment
Cost-effectiveness of e-screening
Time frame: during recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Derived from this study: PubMed 29054833Kingston D, Biringer A, Veldhuyzen van Zanten S, Giallo R, McDonald S, MacQueen G, Vermeyden L, Austin MP. Pregnant Women's Perceptions of the Risks and Benefits of Disclosure During Web-Based Mental Health E-Screening Versus Paper-Based Screening: Randomized Controlled Trial. JMIR Ment Health. 2017 Oct 20;4(4):e42. doi: 10.2196/mental.6888.
- Derived from this study: PubMed 28389421Kingston D, Austin MP, Veldhuyzen van Zanten S, Harvalik P, Giallo R, McDonald SD, MacQueen G, Vermeyden L, Lasiuk G, Sword W, Biringer A. Pregnant Women's Views on the Feasibility and Acceptability of Web-Based Mental Health E-Screening Versus Paper-Based Screening: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 7;19(4):e88. doi: 10.2196/jmir.6866.
- Derived from this study: PubMed 24383441Kingston D, McDonald S, Biringer A, Austin MP, Hegadoren K, McDonald S, Giallo R, Ohinmaa A, Lasiuk G, MacQueen G, Sword W, Lane-Smith M, van Zanten SV. Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial. Trials. 2014 Jan 2;15:3. doi: 10.1186/1745-6215-15-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn A Kingston, Ph.D principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-screening in people with Depression and Anxiety, run by University of Calgary at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01899534, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.